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Implementation of CT-P13 via a Managed Switch Programme in Crohn’s Disease: 12-Month Real-World Outcomes

  • Nikolas Plevris
  • Gareth R. Jones
  • Philip W. Jenkinson
  • Mathew Lyons
  • Cher S. Chuah
  • Lynne M. Merchant
  • Rebecca J. Pattenden
  • Eleanor F. Watson
  • Gwo-Tzer Ho
  • Colin L. Noble
  • Shahida Din
  • Alan G. Shand
  • Ian D. Arnott
  • Charlie W. Lees
Original Article

Abstract

Background

Switching from Remicade to CT-P13 allows for significant cost savings and has been shown to be non-inferior to continued therapy with Remicade for the treatment of Crohn’s disease.

Aim

The aim of this work was to prospectively evaluate clinical outcomes in a cohort of patients with Crohn’s disease switching from Remicade to CT-P13.

Methods

A prospective service evaluation was performed. The Harvey-Bradshaw index, CRP, faecal calprotectin and serum for infliximab/antibody levels were collected prior to patients' final Remicade infusion and at 6 and 12 months after switching to CT-P13 as part of routine clinical care. All adverse events during follow-up were also recorded.

Results

One hundred and ten patients on Remicade switched to CT-P13. No significant difference was observed between the Harvey-Bradshaw Index (p = 0.07), CRP (p = 0.13), faecal calprotectin (p = 0.25) or trough infliximab levels (p = 0.47) comparing before and at 6 and 12 months after the switch to CT-P13. Seven patients developed new infliximab antibodies after switching from Remicade to CT-P13. The majority of patients remained on CT-P13 at 12 months (84.5%) and the rate of adverse events and serious adverse events was 53.8 and 13.5 per 100 patient-years of follow-up, respectively. Switching to CT-P13 resulted in a cost saving of approximately 46.4%.

Conclusion

The transition to CT-P13 from Remicade for the treatment of Crohn’s disease is safe and has no negative effect on clinical outcomes at 12 months.

Keywords

Infliximab CT-P13 Biosimilar Crohn’s disease 

Notes

Acknowledgments

We acknowledge all the staff at the day unit infusion suite, Ward 75, Western General Hospital, Edinburgh, for their help and assistance with this work.

Author's contribution

NP designed the study, collected and analysed the data, wrote the manuscript. GRJ collected and analysed the data, critically revised the manuscript. PWJ collected the data and critically revised the manuscript. ML analysed the data and critically revised the manuscript. CSC, LMM, RJP collected the data and critically revised the manuscript. EFW, GH, CLN, SD, AGS, IDA designed the study and critically revised the manuscript. CWL designed the study, analysed the data and critically revised the manuscript. All authors approved the final version of the manuscript.

Compliance with ethical standards

Conflict of interest

NP has received consultancy fees from Takeda and speaker fees and travel support from AbbVie, Takeda and Norgine. EFW has received travel support from AbbVie. SD has received travel support from AbbVie and Dr. Falk. CLN has received consultancy fees from Vifor. AGS has received travel support from AbbVie. IDA has received consultancy fees from Vifor and travel support from Shire. CWL has received research support from AbbVie and Shire, consultancy fees from AbbVie, Pfizer, Dr. Falk, Hospira, MSD, Pharmacosmos, Takeda and Vifor, and speaker fees and travel support from AbbVie, Pfizer, Dr. Falk, Ferring, Hospira, MSD, Shire, Takeda and Warner-Chilcott. GRJ, PWJ, ML, CSC, LMM, RJP, and GTH have no personal interests to declare.

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Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2018

Authors and Affiliations

  • Nikolas Plevris
    • 1
  • Gareth R. Jones
    • 1
  • Philip W. Jenkinson
    • 1
  • Mathew Lyons
    • 1
  • Cher S. Chuah
    • 1
  • Lynne M. Merchant
    • 1
  • Rebecca J. Pattenden
    • 2
  • Eleanor F. Watson
    • 1
  • Gwo-Tzer Ho
    • 1
  • Colin L. Noble
    • 1
  • Shahida Din
    • 1
  • Alan G. Shand
    • 1
  • Ian D. Arnott
    • 1
  • Charlie W. Lees
    • 1
  1. 1.The Edinburgh IBD UnitWestern General HospitalEdinburghUK
  2. 2.Department of Clinical BiochemistryWestern General HospitalEdinburghUK

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